Project

Download as docx, pdf, or txt
Download as docx, pdf, or txt
You are on page 1of 27

CAPSULE SECTION

LIQUID SECTION
CAPSULES: -

Capsule is the most versatile of all dosage forms. Capsules are solid dosage forms
in which one or more medicinal and inert ingredients are enclosed in a small shell
or container usually made of gelatin.

There are two types of capsules, “hard” and “soft”. The hard capsule is also called
“two piece” as it consists of two pieces in the form of small cylinders closed at one
end, the shorter piece is called the “cap” which fits over the open end of the longer
piece, called the “body”. The soft gelatin capsule is also called as “one piece”.
Capsules are available in many sizes to provide dosing flexibility. Unpleasant drug
tastes and odors can be masked by the tasteless gelatin shell. The administration of
liquid and solid drugs enclosed in hard gelatin capsules is one of the most
frequently utilized dosage forms.

ADVANTAGE OF CAPSULES:

 Capsules mask the taste and odor of unpleasant drugs and can be easily
administered.
 They are attractive in appearance.
 They are slippery when moist and, hence, easy to swallow with a draught of
water.
 As compared to tablets less adjuncts are required.
 The shells are physiologically inert and easily and quickly digested in the
gastrointestinal tract.
 They are economical.
 They are easy to handle and carry.
 The shells can be opacified (with titanium dioxide) or colored, to give
protection from light.

DISADVANTAGE OF CAPSULES:-
 The drugs which are hygroscopic absorb water from the capsule shell making
it brittle and hence are not suitable for filling into capsules.
 The concentrated solutions which require previous dilution are unsuitable for
capsules because if administered as such lead to irritation of stomach.
TYPES OF CAPSULES:-

 Hard Gelatin Capsules


 Soft Gelatin Capsules

Difference in the hard gelatin & soft gelatin capsules is that soft gelatin capsule
contains more plasticizer.

RAW MATERIALS FOR CAPSULES:-

The raw materials used in the manufacture of both hard and soft gelatin capsules
are similar. Both contain gelatin, water, colorants and optional materials such as
process aids and preservatives.

1. GELATIN –gelatin is the major component of the capsules and has been the
material from which they have traditionally been made. Gelatin has been the raw
material of choice because of 3
the ability of a solution to gel to form a solid at a temperature just above ambie
nt temperate conditions, which enables a homogeneous film to be formed rapidly
on a mould pin.

The reason for this is that gelatin possesses the following basic properties:
• It is non-toxic, widely used in foodstuffs and acceptable for use worldwide.
• It is readily soluble in biological fluids at body temperature.
• It is good film-forming material, producing a strong flexible film
• The gelatin films are homogeneous in structure, which gives them strength.
PRODUCTION OF GELATIN:-

On a commercial scale, gelatin is made from by-products of the meat and leather
industry, mainly pork skins, pork and cattle bones, or split cattle hides. Contrary to
popular belief, horns and hooves are not commonly used. The raw materials are
prepared by different curing, acid, and alkali processes which are employed to
extract the dried collagen hydrolysate. The entire process takes several weeks.

2. COLORANTS: - The color of pharmaceutics product plays an important role in


their use. Color is used principally to identify a product in all stages of its
manufacture and use. In the manufacturing company it assists in complying with
GMP norms by helping the operators differentiate between products. The colorants
that can be used in capsules are of two types: water soluble dyes or insoluble
pigments.To make a range of colors dyes and pigments are mixed together as
solutions or suspensions. Three most commonly used dyes are erythrosine, indigo
carmine and quinolone yellow. The two types of pigments used are iron oxides-
black, red and yellow and titanium dioxide which are white and used to make the
capsule opaque. Capsules are colored by the addition of colorants to the gelatin
solution during the manufacturing stage.

3. PRESERVATIVE: - Preservatives and surfactants are added to the gelatin


solution during capsule manufacture to aid in processing. Gelatin solutions are an

ideal medium for bacterial growth at temperatures below 55 C. preservatives are
added to the gelatin and colorant solutions to reduce the growth of microorganisms
until the moisture content of the gelatin film is below 16% w/v.The materials used
as preservatives include: sulfur dioxide which is added as the sodium salts bi
sulfite or meta bi sulfite, ascorbic acid or the methyl propyl esters of Para hydroxy-
benzoic acid, and the organic acids, benzoic and propanoic acids.

HARD GELATIN CAPSULES:-


Hard capsules are usually made up of a base containing plasticizer and water. The
base may also contain preservatives, colors, flavors and sugars.

METHOD OF PRODUCTION EMPTY HARD GELATIN CAPSULES


SHELLS: -

The metal moulds at room temperature are dipped into a hot gelatin solution,
which gels to form a film. This is dried, cut to length, removed from the moulds
and the two parts are joined together, these processes are carried out as a
continuous process in large machines.
The completely automatic machine most commonly used for capsule production
consists of mechanisms for automatically dipping, spinning, drying, stripping,
trimming, and joining the capsules.
• Stainless steel pins are used on which the capsule is formed and controls some of
the final critical dimensions of the capsule.
• One hundred and fifty pairs of these pins are dipped in to gelatin sol of carefully
controlled viscosity to form caps and bodies simultaneously. The pins are usually
rotated to distribute the gelatin uniformly, during which time the gelatin may be set
or gelled by a blast of cool air.
• The pins are moved through a series of controlled air drying kilns for the gradual
and precisely controlled removal of water. The capsules are striped from the pins
by bronze jaws and trimmed to length by stationary knives while the capsule
halves are being spun in chuks or collets. After being trimmed to exact length, the
cap and body sections are joined and ejected from the machine. The entire cycle of
the machine lasts approximately 45 min.
• Thickness of the capsule wall is controlled by the viscosity of the gelatin solution
and the speed and time of dipping. Mold pin dimensions, precise drying, and
machine control relating to cut lengths are matters that are critical to the final
dimensions. Precise control of drying conditions is essential to the ultimate quality
of the cast film.
TYPES OF MATERIALS FOR FILLING INTO HARD GELATIN
CAPSULES:-

Dry solids -powders, pellets, granules or tablets


Semisolids - suspensions or pastes
Liquids -non-aqueous liquids

HAND OPERATED HARD GELATIN CAPSULES FILLING MACHINE:-

Hand operated and electrically operated machines are in practice for filling the
capsules but for small and quick dispensing hand operated machines are quite
economical.

(HAND FILLING CAPSULE MACHINE)


A hand operated gelatin capsule filling machine consists of the following parts.
1. A bed with 200-300 holes.
2. A capsule loading tray
3. A powder tray
4. A pin plate having 200 or 300 pins corresponding to the number of holes in
the bed and capsule loading tray.
5. A lever
6. A handle
7. A plate fitted with rubber top.

All parts of the machine are made up of stainless steel. The machines are
generally supplied with additional loading trays, beds, and pin plates with
various diameters of holes so as to fill the desired size of the capsules. These
machines are very simple to operate, can be easily dismantled and reassembled

WORKING:-

The empty capsules are filled into the loading tray which is then placed over the
bed. By opening the handle, the bodies of the capsules are locked and caps
separated in the loading tray itself which is then removed by operating the liver.
The weighed amount of the drug to be filled in the capsules is placed in powder
tray already kept in position over the bed. Spread the powder with the help of a
powder spreader so as to fill the bodies of the capsules uniformly. Collect excess of
the powder on the platform of the powder tray. Lower the pin plate and move it
downward so as to press the powder in the bodies. Remove the powder tray and
place the caps holding tray in position. Press the caps with the help of plate with
rubber top and operate the lever to unlock the cap and body of the capsules.
Remove the loading tray and collect the filled capsules in a tray. With 200 hole
machine about 5000 capsules can be filled per hour and with 300 hole machine
7500 capsules can be filled per hour.
CAPSULE FILLING POROCESS:-

SIZE OF HARD GELATIN CAPSULES:-

(SIZE OF CAPSULES)
SOFT GELATIN CAPSULE :-

A soft gel (a soft gelatin capsule) is a solid capsule (outer shell) surrounding a
liquid or semi-solid center (inner fill). An active ingredient can be incorporated
into the outer shell, the inner fill, or both.

(SOFT GELATIN CAPSULE)


The formulation of drugs into soft gelatin capsules has gained popularity
throughout the past decade due to the many advantages of this dosage form. The
bioavailability of hydrophobic drugs can be significantly increased when
formulated into soft gelatin capsules. Many problems associated with tableting,
including poor compaction and lack of content or weight uniformity, can be
eliminated when a drug is incorporated into this dosage form.
Gelatin soft capsules are made from gelatin and water but with the addition of a
polyhydic alcohol, such as glycerol or sorbitol, to make them flexible. Sorbitol is
less hygroscopic than glycerol. They usually contain a preservative, such as beta-
naphthol. They are available in variety of shapes and sizes.
• Spherical – 0.05 -5 ml
• Ovoid – 0.05 - 7 ml
• Cylindrical – 0.15- 25 ml
• Tubes – 0.5 - 0 ml
• Pear shaped – 0.3 - 5ml

They are most suitable for liquids and semisolids and are widely used, in spherical
and ovoid forms for vitamin preparations such as cod liver oil, vitamins A and D
and multiple vitamins.
ADVANTAGE:-
1. Ease of use - easy to swallow, no taste, unit dose delivery, temper proof.
2. Versatile
i. Accommodates a wide variety of compounds filled as a
semisolid, liquid, gel or paste.
ii. Wide variety of colors, shapes and sizes
iii. Immediate or delayed drug delivery-can be used to improve
bioavailability by delivering drug in solution or other
absorption enhancing media

DISADVANTAGE:-
1. Requires special manufacturing equipment
2. Stability concerns with highly water soluble compounds, and
compounds susceptible to hydrolysis
3. Limited choices of excipients/carriers compatible with the
gelatin

Content of a softgel capsule is a liquid, or a combination of miscible liquids, a


solution of a solid(s) in a liquid(s) or a suspension of a solid(s) in a liquid(s).
Liquids are an essential part of the capsule content. Only those liquids that are both
water miscible and volatile cannot be included as major constituents of the capsule
content since they can migrate into the hydrophilic gelatin shell and volatilize from
its surface. Water, ethyl alcohol and emulsions fall into this category.

FORMULATION OF SOFT GELATIN CAPSULES :-

GELETIN SHELL FORMULATION:- Typical soft gels are made up of gelatin,


plasticizer, and materials that impart the desired appearance (colorants and/or
opacifiers), and sometimes flavors.

Soft capsules are usually formed, filled, and sealed in one operation. However,
shells for extemporaneous use are sometimes prefabricated. Liquids may be
incorporated directly. Solids are usually dissolved or dispersed in a suitable
excipient(s) to give a solution, suspension or dispersion of paste-like consistency.
In-process controls during soft capsule production should include the viscosity of
the contents, and the uniformity of mass, capsule size, integrity of the seals, and
disintegration or dissolution rate (e.g. for modified-release capsules) of the finished
dosage form.
PLASTICIZERS:-
These are used to make the soft gel shell elastic and pliable. They usually account
for 20-30%. The most common plasticizers used in soft gels is glycerol, although
sorbitol and propylene glycol are used frequently often in combination with
glycerol. The amount and choice of the plasticizer contribute to the hardness of the
final product and may even affect its dissolution or disintegration characteristics,
as well as its physical and chemical stability. Plasticizers are selected on the basis
of their compatibility with the fill formulation, ease of processing, and the desired
properties of the final soft gel, including hardness, appearance, handling
characteristics and physical stability. One of the most important aspect of soft gel
formulation is to ensure that there is minimum interaction or migration between the
liquid fill matrix and the soft gel shell.

WATER:-
The other essential component of the soft gel shell is water. Water usually accounts
for 30-40 % of the wet gel formulation and its presence is important to ensure
proper processing during gel preparation and soft gel encapsulation. Following
encapsulation, excess water is removed from the soft gels through controlled
drying. In dry gels the equilibrium water content is typically in the range 5-8%
w/w, which represents the proportion of water that is bound to the gelatin in the
soft gel shell. This level of water is important for good physical stability, because
in harsh storage conditions soft gels will become either too soft and fuse together,
or too hard and embrittled.

COLORANT/OPACIFIERS:-Colorants (soluble dyes, or insoluble pigments or


lakes) and opacifiers are typically used in the wet gel formulation. Colorants can
be either synthetic or natural, and are used to impart the desired shell color for
product identification. An opacifier, usually titanium dioxide may be added to
produce an opaque shell when the fill formulation is a suspension, or to prevent
photo degradation of light-sensitive fill ingredients. Titanium dioxide can either be
used alone to produce a white opaque shell or in combination with pigments to
produce a colored opaque shell.
PRODUCT FORMULATION BECOSULE:-

 Folic acid- VIT B9 - 1. 5 MG


Niacinamide - 100 MG
 Calcium Pantothenate - 50 MG
 Pyridoxine - 3 MG
 Ascorbic Acid - 150 MG
 Riboflavin - 10 MG
 Thiamine - 10 MG
 Biotin - 100 MCG

 For Therapeutic use


PROCESS OF MANUFACTURING
CAPSULE
STEP- I
Based on production plan prepare batch seat & authenticate from section incharge.
Make issue indent slip & obtained material from store.
STEP- II
Weighed the material & pass through sieve No. 40
STEP- III
Transferred the sieved material in to planetary mixture, cover it & blend it for 30
minutes.
STEP- IV
Send in process sample to Q.C. for testing of drug under sample testing active covering
particulars of the batch & theoretical average weight. trasfer the bulk of P.V.C. bags
contained in fiber drum like the bags cover & label.
STEP- V
On receipt of the report from Q.C. transfer the material to production area. Encapsulate
powder on the basis of drug content, reporting by Q.C. in semi automatic filling
machines. Moniter average weight at 30 min. interval & maintained nrecord on printed
performa.
STEP- VI
Send setting advice to Q.C. for drawing sample on printed performa. Stored the filling
capsule in P.V.C. bag contained in fibers drums. Tie the bags cover the drums & labled
& keep in quarantine.

MANUFACTURE OF SOFT GELATIN CAPSULES:-

ROTARY CAPSULE MACHINE:- This machine has two, side-by-side cylinders


in each of which half-moulds are cut. These cylinders, like the rollers of a mangle,
rotate in contrary direction and as they are mirror images the moulds come together
precisely during rotation. Two ribbons of gelatin are fed between the rollers and,
just before the opposing rollers meet, jets of medicament press the gelatin ribbon
into the moulds, filling each half.
The moment of pressure follows, immediately sealing the two halves together to
form a capsule. These rotary machines are capable of producing between 25000
and 30000 capsules an hour with an accuracy of dosage of approximately ± 1
percent.

(AUTOMATIC SOFT GELATIN ENCAPSULATION MACHINE)


(AUTOMATIC CAPSULE MACHINE)

(AUTOMATIC FILLER CAPSULE MACHINE)


CLEANING AND PACKAGING :-

It is imperative that every precaution to minimize traces of moisture or body oils


on capsules be taken to reduce powders sticking to the surface, which would create
disagreeable appearance and taste. Cleaning capsules is difficult if they have
become moist or sticky. The capsules should be handled so that they retain their
dryness and shiny appearance. Use of gloves provides a more hygienic
environment and helps preserve the dry, shiny capsule appearance. An old method,
where gloves are unavailable, is:
(1) Wash and dry hands thoroughly,
(2) keep the fingers dry by the friction of a towel that is stripped through the tightly
clenched fingers until a clearly perceptible heat is generated,
(3) Four or five capsules may be prepared before there will be a need to repeat the
process. If the capsules have been kept dry, clinging surface powder can be
removed by rolling between folds of a cloth or by shaking in a cloth formed into a
bag or hammock. Another method of cleaning capsules is to place them in a
container that is filled with sodium bicarbonate, sugar or salt then gently to roll the
container. The contents then can be poured into a 10 mesh sieve and the “cleaning
salt” allowed to pass through the screen, which collects the capsules. It must be
emphasized that these cleaning methods are only effective if the capsules have
been kept clean and dry. Once capsules become soiled and dull, they cannot be
cleaned effectively.

(CAPSULE PACKAGING MACHINE)


QUALITY CONTROL OF CAPSULES:-

Whether capsules are produced on a small scale or large scale all of them are
required to pass not only the disintegration test, weight variation test and
percentage of medicament test but a visual inspection must be made as they roll off
the capsule machine onto a conveyor belt regarding uniformity in shape, size, color
and filling. As the capsules moves in front of the inspectors the visibly defective or
suspected of being less than the perfect are picked out.
The hard and soft gelatin capsules should be subjected to following tests for their
standardization.
1. Shape and size
2. Color
3. Thickness of capsule shell
4. Leaking test for semi-solid and liquid ingredients from soft capsules
5. Disintegration tests
6. Weight variation test
7. Percentage of medicament test

In official books the following quality control tests are recommended for capsules:

DISINTEGRATION TEST:-For performing disintegration test on capsules the


tablet disintegration test apparatus is used but the guiding disc may not be used
except that the capsules float on top of the water. One capsule is placed in each
tube which are then suspended in the beakers to move up and down for 30 minutes,
unless otherwise stated in the monograph. The capsules pass the test if no residue
of drug or other than fragments of shell remains on No. 10 mesh screen of the
tubes.

WEIGHT VARIATION TEST: - 20 capsules are taken at random and weighed.


Their average weight is calculated, then each capsule is weighed individually and
their weight noted. The capsule passes the test if the weight of individual capsule
falls within 90-110% of the average weight. If this requirement is not met, then the
weight of the contents for each individual capsule is determined and compared
with the average weight of the contents. The contents from the shells can be
removed just by emptying or with the help of small brush. From soft gelatin
capsules the contents are removed by squeezing the shells which has been carefully
cut. The remainder contents are removed by washing with a suitable solvent. After
drying the shells, they are weighed and the content weights of the individual
capsules are calculated. The requirements are met if -
(1) not more than 2 of the differences are greater than 10 % of the average net
content and
(2) in no case the difference is greater than 25 %.

CONTENT UNIFORMITY TEST:-


This test is applicable to all capsules which are meant for oral administration. For
this test a sample of the contents is assayed as described in individual monographs
and the values calculated which must comply with the prescribed standards.

CAPSULE STABILITY CAPSULES:-


Unprotected soft capsules (i.e., capsules that can breathe) rapidly reach equilibrium
with the atmospheric conditions under which they are stored. This inherent
characteristic warrants a brief discussion of the effects of temperature and humidity
on these products, and points to the necessity of proper storage and packaging
conditions and to the necessity of choosing an appropriate retail package. The
variety of materials capsulated, which may have an effect on the gelatin shell,
together with the many gelatin formulations that can be used, makes it imperative
that physical standards are established for each productct.
General statements relative to the effects of temperature and humidity on soft
gelatin capsules must be confined to a control capsule that contains mineral oil,
with a gelatin shell having a dry glycerin to dry gelatin ratio of about 0.5 to 1 and a
water to dry gelatin ratio of 1 to 1, and that is dried to equilibrium with 20 to 30 %

RH at 21 to 24 C, the physical stability of soft gelatin capsules is associated
primarily with the pick-up or loss of water by the capsule shell. If these are
prevented by proper packaging, the above control capsule should have satisfactory

physical stability at temperature ranging from just above freezing to as high as 60
C, for the unprotected control capsule, low humidities (less than 20 % RH), low
○ ○
temperature (less than 2 C) and high temperatures (greater than 38 C) or
combinations of these conditions have only transient effects. The capsule returns to
normal when returned to optimum storage conditions.
NAME OF MANUFACTURED PRODUCT LIST(CAPSULES):-
vibgyor Laboratories Pvt. Ltd. produces an absolute range of pharmaceutical
formulation Capsules. Following is the list of capsules with its Product name,
compositions, therapeutic classifications, as well as pack sho
Becosules Capsule - Composition and Active Ingredients

S.N. PRODUCT NAME COPMPOSITION USE


1 Becosules Capsule  Folic Acid - Vitamin B9 -  Acne
1.5 MG  Hair loss
 Vitamin B12 - 15 MCG  Vitamin deficiency
 Niacinamide - 100 MG  Vitamin b12 deficiency
 Calcium Pantothenate - 50  Hair fall
MG  Supplements
 Pyridoxine - 3 MG  Muscle cram
 Ascorbic Acid - 150 MG
 Riboflavin - 10 MG
 Thiamine - 10 MG
 Biotin - 100 MCG
Liquid section;-

INTRODUCTION:-

VIBGYOR Laboratories Pvt. Ltd. produces an absolute range of pharmaceutical


formulation Liquid Oral.
SYRUP-

Syrup is a concentrated or nearly saturated solution of sucrose in purified water.


The concentration of sugar is 66.7% w/v. The syrup are sweet viscous
preparations. The syrups containing medicinal substances are called medicated
syrup. And those containing aromatic or flavored substances are known as flavored
syrup.

Or

In cooking, a syrup or syrup (From Arabicsharab, beverage, wine, via Latinsirupus


is a thick, viscous liquid consisting primarily of a solution of sugar in water,
containing a large amount of dissolved sugars but showing little tendency to
deposit crystals.

TYPES OF SYRUP:-
1. Aromatic or Adjuvant Syrup
2. Medicated Syrup
 Aromatic or Adjuvant Syrup:-
They are mostly used to improve the taste of salty, bitter, or otherwise unpleasant
mixtures.
 Medicated Syrup:-

They are of two types:


1 Made from extractive drugs: Here, the fluid extract of the respective
medicines is mixed with the syrup.
2 Made from chemicals: This can be either by simple solution or by chemical
reaction and solution. Here the taste of the medicinal agents is greatly
modified.
ADVANTAGE OF SYRUP:-

 It is a valuable vehicle for the administration of nauseous substances.


 Syrups have high osmotic pressure which prevent bacterial growth.
 It Prevents decomposition of many vegetable substance.
 They are palatable, Due to sweetness of sugar.

DISADVANTAGE OF SYRUP:-

 Less dosage accuracy.


 Problem occurs in preservation.
 Transport is very much difficult.
 No recovery is possible if it lost one time.

FORMULATION OF SYRUP:-

VEHICLE:-Syrup are prepared by using the purified water.


ADJUVENTS:-Following adjuvants added—

 Chemical Stabilizers: Glycerin, Sorbitol and Propylene glycol is added in


small quantity to the syrup to prevent the crystallization.
 Colouring Agents:Many Syrup are attractively colored with Coal tar dyes
such as Amaranth , Compound tartrazine and Greens.
 Flavouring Agent:-Following flavouring agents are added—
1. Tincture lemon and tincture ginger.
2. Fruit juice, rash berry juice, wild cherry.
3. Essence vanilla, Orange.
 Preservatives:-Generally benzoic acid, Sodium benzoate, Methyl paraben
are commonly used in appropriate concentration.
PRODUCT LIST OF VIGGYOR LABORATORY:-

I. KOFGON SYRUP ;-

COMPOSITION:-
Each 5ml. contains
Salbutamol - I.P. 2.00 mg.
Bromhexine hydrochloride - I.P. 4.00 mg.
Benzoic Acid - I.P. 20.00 mg.
(As preservative)
Flavored Syrupy Base - q.s.
Colour - Sunset Yellow

vMANUFACTURING PROCESS:-
 Syrup base is added to the container fixed with accessory equipment.

 The base is distilled as per the need. The agitator is then started.
Solubilisation is then done & solvents are added to it.
 Active ingredients are then added to the mixture.

 Colorants after solubilizing in suitable solvents are added.

 pH is maintained & Flavouring agent are added.

 Volume is made up with de ionized water.


 Sample is sent to Q.C. department and filtration is carried out.
 The filtered mass is filled in suitable containers with filling machine.

 The filled bottles are checked for any cracks.

 Those bottles are then sealed & again checked for any cracks.
 Sampling, labeling& packaging is then done.

PHARMACEUTICAL APPLICATIONS :

All types of throat congestitis, irritation, cough, acute bronchitis, bronchial asthma,
tropical oesonophilia.

BOTTLE LIQUID FILLING MACHINE:-

Automatic Syrup Filling Machine is compact, versatile and enclosed in stainless


steel elegantly matt finish body. This unit works on volumetric principal and
reciprocating self-centering device.
LIQUID SEALING MACHINE:-

Bottle Cap Sealing Machine : Portable, hand operated equipment with two extra
cap holders of different sizes. Totally casted machine hand operated
REFERENCES-

1. Mehta R.M, “Pharmaceutics-I” IVTH edition VallabhPrakashan (page no-


269-274).
2. Leon lachman,Herbert A Lieberman, “The Theory And Practice Of
Industrial Pharmacy” Special Indian Edition-2009 CBS Publisher &
Distributors pvt.ltd (page no-374,392 )
3. Aulton M.E “Pharmaceutics” Churchill livingstone publication IInd edition(
page no-449)

You might also like